The Emergency Department Stopping Elderly Accidents, Deaths and Injuries Program

NCT02167737 | Completed

• 1 other identifier: #PRO-00001450
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine if a bedside decision aid used in the ED for mechanical fall prevention can increase patient participation in management options that decrease their fall risk. Additionally, the investigators aim to determine if there are gender differences in patient choices in management options and accomplished goals inspired by the decision tool.

Conditions

Accidental Falls; Falling Injury; Other and Unspecified Fall on Same Level

Keywords

Accident Prevention; Accidental Falls; Geriatric Health Services; Gender Differences

Outcome Measures

Primary Outcomes (1)

• Efficacy of the bedside decision tool/worksheet

  A single sheet bedside decision aid form/worksheet will be used to engage the patient in a discussion about fall prevention, the aim of which is to increase patient interest and participation in different management options that decrease fall risk. Patients will be followed up via phone calls re: their management option choices and how thorough/successful they were in completing them.

  12 months

Secondary Outcomes (1)

• Gender differences in use of the decision tool

  12 months

Other Outcomes (1)

• Gender differences in fall management choices

  12 months

Study Arms (2)

Bedside Decision Aid Group

EXPERIMENTAL

This arm will include study participants who are randomized to the group utilizing the bedside decision aid, which has hospital staff arrange fall-risk reduction interventions (e.g., home safety checks, exercise programs, vision checks, etc.).

Behavioral: Bedside Decision Aid

Control Arm

ACTIVE COMPARATOR

Participants in the control/comparator arm will experience the same study procedures with the exception of not using the Bedside Decision Aid and instead being given the Centers for Disease Control (CDC) brochure, "What You Can Do to Prevent Falls," and arranging for their own fall prevention strategies.

Behavioral: Control Arm

Interventions

Bedside Decision Aid BEHAVIORAL

This group will have an initial FES and VES screening completed in the ED, the TUG test and Chair 30-Second Stand test, and the participant's risk of falling evaluated using our Bedside Decision worksheets. A study team member explains what subjects can do to decrease their risk of falling and discuss what mobility goals are the most important to them. Participants will receive a follow-up telephone call approximately six weeks after their discharge from the ED to collect self-reported data about goal completion, and then at four additional times--three, six, nine and 12 months--over the course of a year to collect self-reported data such as fall history.

Bedside Decision Aid Group

Control Arm BEHAVIORAL

This group will also have an initial FES and VES screening completed in the ED and the same two mobility tests (TUG and Chair 30-Second Stand). Study staff will advise subjects on how to take action to prevent falls and give them a brochure, "What YOU Can Do to Prevent Falls," from the CDC's "STEADI Tool Kit for Health Care Providers." Participants will receive a telephone call approximately six weeks after their discharge from the ED to collect self-reported data about goal completion, and then at four additional times--three, six, nine and 12 months--over the course of a year to collect self-reported data such as fall history.

Control Arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients must:
• Be 65 years of age or older
• Be discharged home from the ED
• Be able to speak English.
• Be competent and able to give consent (not in critical condition, intoxicated or otherwise incapacitated)
• Have a mechanical fall risk as defined by one of the following:
• Reports to have fallen in the last year Reports worrying about falling Admits they feel unsteady when standing or walking

You may not qualify if:

• Patients must not:
• Be younger than 65 years old
• Be discharged from the ED to anywhere, but home (i.e., must not be discharged to family member's home, personal care facility, nursing home, group home, etc.)
• Be unable to speak English
• Be incompetent and unable to give consent (in critical condition, intoxicated or otherwise incapacitated)

Sponsors & Collaborators

• Lehigh Valley Hospital: lead

Study Sites (1)

Lehigh Valley Hospital, Emergency Medicine Research

Bethlehem, Pennsylvania, 18017, United States

Location

Study Officials

• Marna R. Greenberg, DO, MPH

  Lehigh Valley Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Emergency Medicine Research

Study Record Dates

• First Submitted: June 14, 2014
• First Posted: June 19, 2014
• Study Start: May 1, 2014
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: August 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)